U.S. patent application number 13/795490 was filed with the patent office on 2014-06-05 for medical device anchoring apparatus and methods.
This patent application is currently assigned to Medtronic, Inc.. The applicant listed for this patent is MEDTRONIC, INC.. Invention is credited to Bruce A. Behymer, Eric H. Bonde.
Application Number | 20140155860 13/795490 |
Document ID | / |
Family ID | 50826132 |
Filed Date | 2014-06-05 |
United States Patent
Application |
20140155860 |
Kind Code |
A1 |
Behymer; Bruce A. ; et
al. |
June 5, 2014 |
MEDICAL DEVICE ANCHORING APPARATUS AND METHODS
Abstract
Methods and apparatus for anchoring an elongate medical device
within a body portal, for example, a stimulation lead in a cranial
burr hole, employ opposing engagement surfaces, spring biased
toward one another. A retaining member may be inserted between the
opposing surfaces, to hold the surfaces apart for initial
positioning of the device therebetween. For example, a delivery
catheter in which the device is moved through the body portal can
serve as the retaining member. In one type of apparatus, the
engagement surfaces are formed within an anchoring aperture of one
plate member of a pair of plate members. In another type of
apparatus, the engagement surfaces are formed by sides of a slot
that extend through a ring member and into a plug member, wherein a
portion of the plug member is preferably formed by an elastomer
material, and, in some cases, an entirety of the apparatus.
Inventors: |
Behymer; Bruce A.; (Grant,
MN) ; Bonde; Eric H.; (Minnetonka, MN) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
MEDTRONIC, INC. |
Minneapolis |
MN |
US |
|
|
Assignee: |
Medtronic, Inc.
Minneapolis
MN
|
Family ID: |
50826132 |
Appl. No.: |
13/795490 |
Filed: |
March 12, 2013 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
61733584 |
Dec 5, 2012 |
|
|
|
Current U.S.
Class: |
604/500 ;
604/175 |
Current CPC
Class: |
A61B 2090/103 20160201;
A61M 25/04 20130101; A61B 17/3468 20130101; A61B 2017/347 20130101;
A61B 17/3472 20130101; A61M 2025/024 20130101; A61N 1/36025
20130101; A61M 5/00 20130101; A61B 2034/302 20160201; A61N 1/0539
20130101; A61B 2034/301 20160201; A61B 90/11 20160201 |
Class at
Publication: |
604/500 ;
604/175 |
International
Class: |
A61M 25/04 20060101
A61M025/04 |
Claims
1. A method for anchoring an elongate medical device in a body
portal, the method comprising: positioning the device between
opposing engagement surfaces of an anchoring apparatus, the
engagement surfaces being spring biased toward one another; fixing
the anchoring apparatus to the body so that the apparatus partially
occludes the body portal; and removing a retaining member from
between the opposing engagement surfaces of the fixed anchoring
apparatus to allow the spring bias of the engagement surfaces to
move the surfaces toward one another and into contact with the
inserted device.
2. The method of claim 1, wherein positioning the device comprises
inserting the device through an opening of a slot of the apparatus,
the engagement surfaces being formed by opposing sides of the
slot.
3. The method of claim 2, wherein fixing the apparatus to the body
comprises press fitting a plug portion of the apparatus into the
body portal, the slot extending into the plug portion, and the
opening of the slot extending longitudinally between a bottom
surface of the apparatus and a top surface of the apparatus; and
the method further comprises routing a segment of the inserted
device along a channel formed in an outer perimeter ring of the
anchoring apparatus, the outer perimeter ring surrounding the plug
portion and having the slot extending therethrough.
4. The method of claim 3, wherein the channel formed in the outer
perimeter ring comprises another slot extending from an opening in
the top surface of the anchoring apparatus, the plug portion and
the outer perimeter ring sharing the top surface, and the opening
of the other slot extending radially; and further comprising
wrapping another segment of the inserted device around a perimeter
of the plug portion, beneath the outer perimeter ring, after
routing the segment along the channel, the other segment extending
proximally from the routed segment.
5. The method of claim 1, wherein the retaining member comprises a
catheter; and the device extends within a lumen of the catheter
when the device is positioned between the engagement surfaces of
the apparatus, the device having been moved through the body portal
via passage through the lumen of the catheter.
6. The method of claim 5, wherein: the anchoring apparatus is one
of a pair of plate members of an anchoring assembly; fixing the
anchoring apparatus to the body comprises securing a first plate
member of the pair of plate members to the body with the second
plate member of the pair of plate members being captured between
the first plate member and the body, and then securing the second
plate member to the body, the second plate member being the
anchoring apparatus; the first plate member includes an opening
that provides access to the opposing engagement surfaces of the
captured anchoring apparatus; and the method further comprising
adjusting a position of the captured second plate member relative
to the body portal and relative to the secured first plate member,
prior to securing the second plate member to the body.
7. The method of claim 6, wherein positioning the device between
the opposing engagement surfaces follows the securing of the first
plate member to the body with the second plate member being
captured between the first plate member and the body, and precedes
the securing the second plate member to the body.
8. An anchoring apparatus for an elongate medical device, the
apparatus comprising: a plug portion including opposing engagement
surfaces and a press fit feature defining an outer perimeter
surface of the plug portion, the engagement surfaces being spring
biased toward one another to anchor the medical device
therebetween; and a ring member extending around a perimeter of the
plug portion, above the press fit feature, the ring member
including at least one channel to receive a segment of the device
when the device is anchored between the engagement surfaces;
wherein a slot extends from an opening thereof, formed through the
ring member, and into the plug portion, the engagement surfaces of
the plug portion being formed by opposing sides of the slot.
9. The anchoring apparatus of claim 8, wherein: the plug portion
comprises a spring member creating the spring bias for the
engagement surfaces, the spring member including a fixed end and a
pair of opposing arms, the fixed end being coupled to the ring
member, and each arm extending from the fixed end to a
corresponding moveable end thereof located adjacent the slot
opening; and the opposing arms of the spring member define the
opposing sides of the slot, which form the engagement surfaces of
the plug portion.
10. The anchoring apparatus of claim 9, wherein the plug portion
further includes an elastomer material, which extends between each
arm of the spring member and an inner perimeter surface of the ring
member on either side of the slot.
11. The apparatus of claim 9, wherein movable ends of the arms of
the spring member are supported by an inner perimeter surface of
the ring member.
12. The apparatus of claim 9, further comprising a retaining
member, the retaining member being configured to engage with, and
disengage from the spring member, between the arms thereof, the
engaged retaining member holding the engagement surfaces apart from
one another against the spring bias, and the disengaged retaining
member allowing the engagement surfaces to move toward one another
according to the spring bias.
13. The apparatus of claim 9, further comprising a separate cap
configured to cover the plug portion when fitted within the ring
member, the cap including a first perimeter tab and a second,
compressible perimeter tab, opposite the first perimeter tab; and
wherein: the ring member protrudes from an upper surface of the
plug portion; the ring member further includes opposing edges
located on either side of the slot opening, and a mounting groove
extending through the ring member opposite the slot opening, each
edge of the opposing edges overhanging the moveable end of the
corresponding arm of the spring member of the plug portion; and
when the cap is fitted within the ring member to cover the plug
portion, the first perimeter tab is located beneath the overhang of
the opposing edges of the ring member, and the second compressible
perimeter tab is held within the mounting groove of the ring
member.
14. The apparatus of claim 8, wherein the plug portion and ring
portion are wholly and integrally formed from an elastomer
material.
15. The apparatus of claim 14, wherein: the plug portion includes a
top section and a bottom surface, the ring member being an outward
extension of the top section, and the outer perimeter surface of
the plug portion extending from the bottom surface toward the top
section; the slot having opposing sides that form the engagement
surfaces of the plug portion is a first slot, the first slot having
an opening along the outer perimeter surface of the plug portion
and a longitudinally extending end wall within the plug portion;
and a second slot extends through the ring member and into the plug
portion from an opening at the top section to a radially extending
end wall, the second slot being the channel of the ring member, and
the second slot communicating with the first slot.
16. The apparatus of claim 15, wherein sides of the second slot
enclose an angle, the angle being between approximately ten degrees
and approximately ninety degrees.
17. The apparatus of claim 15, wherein the ring member further
includes another channel, the other channel extending along a lower
surface of the ring member and about a perimeter of the plug
portion, the lower surface being opposite the top surface.
18. An assembly for anchoring an elongate medical device in a body
portal, the assembly comprising: a first plate member including a
first side, a second side opposite the first side, an inner
perimeter edge that defines an opening through the first plate
member, from the first side to the second side, an outer perimeter
surface, and securing features located in proximity to the outer
perimeter surface and projecting from the second side; and a second
plate member having a thickness that is less than or approximately
equal to a distance over which the securing features of the first
plate member project from the second side thereof, the second plate
member including a first side, a second side opposite the first
side, an anchoring aperture formed through the second plate member
from the first side to the second side, an outer perimeter edge,
and a securing feature located in proximity to the outer perimeter
edge, the anchoring aperture comprising opposing engagement
surfaces that are spring biased toward one another for anchoring
the device in the aperture; and wherein, when the first and second
plate members are positioned adjacent one another, a shape defined
by the outer perimeter edge of the second plate member allows the
anchoring aperture to be located within a boundary of the opening
defined by the inner perimeter edge of the first plate member,
while the securing feature of the second plate member is
simultaneously located outside a boundary defined by the outer
perimeter edge of the first plate member; and when the second plate
member is positioned over the body portal, the first plate member
is positioned over the positioned second plate member, with the
second side of the first plate member facing the first side of the
second plate member, and the securing features of the first plate
member are secured to a surface surrounding the body portal, the
second plate member is captured between the first plate member and
the body portal but is moveable to reposition the aperture thereof
within the boundary of the opening defined by the inner perimeter
edge of the first plate member.
19. The assembly of claim 18, wherein the opposing engagement
surfaces of the anchoring aperture are formed by a dimple spring
clip integrally formed in the second plate member.
20. The assembly of claim 18, wherein the opposing engagement
surfaces of the anchoring aperture are formed by an elastomer
insert of the second plate member.
Description
CROSS-REFERENCE TO RELATED APPLICATION(S)
[0001] The present application claims priority to U.S. Provisional
Patent Application, Ser. No. 61/733,584 (Attorney Docket No.
C00004778.USP1), which was filed on Dec. 5, 2012, and is hereby
incorporated by reference in its entirety. The present application
is related to the following commonly assigned and co-pending United
States Non-provisional Patent Applications, filed concurrently
herewith and having the same title as the instant application, each
of which is hereby incorporated by reference in its entirety:
Attorney Docket No. C00004785.USU1, and Attorney Docket No.
C00004789.USU1.
TECHNICAL FIELD
[0002] The present disclosure pertains to medical devices and more
particularly to various apparatus, assemblies and methods for
anchoring an elongate medical device within a body portal, for
example, a burr hole formed in a skull of a patient.
BACKGROUND
[0003] Medical procedures for treating a variety of neurological
conditions, for example, Parkinson's disease, essential tremor and
dystonia, require access to the brain, typically through a burr
hole formed in the skull, for the insertion of deep brain
stimulating electrodes. Burr holes may also be formed for the
insertion of a delivery catheter, for example, to provide drug
therapy for similar conditions. Stereotactic apparatus and
procedures, which are known to those skilled in the art, may be
employed by surgeons to locate inserted electrodes and/or drug
delivery ports in target regions of the brain.
[0004] FIG. 1A is a perspective view of an exemplary stereotactic
guidance system 100 (e.g. Medtronic Nexdrive Micropositioning Drive
attached to the Medtronic Nexframe.RTM.) mounted to a patient's
skull. FIG. 1A illustrates a ring 120 of guidance system 100, which
extends around a perimeter of a burr hole 11 formed in the skull,
supporting a socket assembly 140 to which a micropositioning drive
160 is attached. Burr hole 11 may be lined with a base ring 112
(FIG. 1B; e.g. the Medtronic Stimloc base) that is mounted around
burr hole 11 prior to attaching ring 120 of guidance system 100.
FIG. 1 further illustrates an elongate medical device 15, for
example, a medical electrical lead carrying one or more stimulating
electrodes, held within drive 160 for advancement through burr hole
11 and into the target region of the brain.
[0005] FIG. 1B illustrates a portion of the implanted device 15,
after guidance system 100 is removed, extending proximally out from
base ring 112, which lines burr hole 11, and which is fastened to
the skull, for example, via screws received through holes 106 in
base ring 112. Those skilled in the art appreciate that a proximal
portion of implanted device 15, outside the cranial space, may be
routed, beneath the scalp and subcutaneously, to a therapy
generator (not shown), for example, implanted in proximity to the
clavicle. FIG. 1B further illustrates device 15 extending through a
slot of base ring 112 so that device 15 may be secured/anchored
between base ring 112 and a cap that snaps into place thereover
(not shown; e.g., the Medtronic Stimloc cap). Although various
configurations of apparatus for securing elongate medical devices
in body portals, such as burr holes, are known in the art, there is
still a need for new and improved anchoring apparatus and methods,
for example, to increase the ease by which anchoring is activated,
without dislodging the implanted device, and without compromising
the stability of anchoring.
BRIEF DESCRIPTION OF THE DRAWINGS
[0006] The following drawings are illustrative of particular
embodiments of the present invention and therefore do not limit the
scope of the invention. The drawings are not to scale (unless so
stated) and are intended for use in conjunction with the
explanations in the following detailed description. Embodiments
will hereinafter be described in conjunction with the appended
drawings wherein like numerals/letters denote like elements,
and:
[0007] FIG. 1A is a perspective view of an exemplary stereotactic
guidance mounted to a patient's skull;
[0008] FIG. 1B shows an exemplary base ring mounted in a burr hole
of the skull;
[0009] FIGS. 2A-B are perspective views of an anchoring apparatus,
according to some embodiments;
[0010] FIG. 2C is an elevation view of an anchoring apparatus,
according to some embodiments;
[0011] FIG. 2D is a perspective view of an anchoring apparatus,
modified from that shown in FIGS. 2A-B, according to some
embodiments;
[0012] FIG. 2E is a perspective view of a cap, which may be
employed with the apparatus of FIG. 2D, according to some
embodiments;
[0013] FIG. 3A is a perspective view (partially transparent) of an
anchoring apparatus, according to some embodiments;
[0014] FIGS. 3B-C are a top plan view and a cross-section view of
the apparatus shown in Figure
[0015] FIG. 3D is a perspective view of an anchoring apparatus,
according to some alternate embodiments;
[0016] FIG. 3E is a bottom plan view of the anchoring apparatus
shown in FIG. 3D, according to some embodiments;
[0017] FIGS. 4A-B are perspective views of an anchoring assembly,
according to yet further embodiments;
[0018] FIG. 4C is a perspective view of an anchoring apparatus,
modified from that shown in FIGS. 4A-B, according to some
embodiments; and
[0019] FIG. 5 is a flow chart outlining some methods of the present
invention.
DETAILED DESCRIPTION
[0020] Embodiments of anchoring apparatus and assemblies, disclosed
herein, are suitable for mounting/fixing in or over a body portal,
for example, a cranial burr hole, in order to anchor in place an
implanted elongate medical device, such as an electrical lead or a
fluid delivery catheter, which is implanted in the body via
insertion through the body portal. The apparatus and assemblies
include various configurations of spring biased engagement
surfaces, which may be retained in an open position while the
elongate medical device is positioned therebetween, either before
or after the apparatus/assembly is fixed relative to the body
portal. Associated methods for employing the various apparatus and
assemblies are disclosed in conjunction with the detailed
description of each exemplary embodiment thereof, and in summary at
the end of the detailed description. The following detailed
description is exemplary in nature and is not intended to limit the
scope, applicability, or configuration of the invention in any way.
Rather, the following description provides practical examples, and
those skilled in the art will recognize that some of the examples
may have suitable alternatives. Examples of constructions,
materials, dimensions and fabrication processes are provided for
select elements and all other elements employ that which is known
by those skilled in the art.
[0021] FIGS. 2A-B are perspective views of an anchoring apparatus
700, according to some embodiments. FIGS. 2A-C illustrate apparatus
700 including a central, or plug portion 70 and ring member 710,
which extends around a perimeter of plug portion 70; a slot 713
extends from an opening thereof, formed through ring member 710,
between outer and inner perimeter surfaces 740, 720 thereof, and
into plug portion 70. FIGS. 2A-B further illustrate plug portion 70
including spring biased opposing engagement surfaces 735 that form
opposing sides of slot 713, wherein opposing sides of slot 713 are
defined by opposing arms 731, 732 of a spring member 730 of plug
portion 70. Spring member 730 is shown including a fixed end 734,
which is coupled to inner perimeter surface 720 of ring member 710,
and from which each of a pair of opposing arms 731, 732 extends to
a corresponding moveable end 707, 708 thereof.
[0022] With further reference to FIGS. 2A-B, each of first and
second moveable ends 707, 708 are contained within inner perimeter
surface 720 of ring member 710 such that ends 707, 708 are
slideable therealong, to be opened, away from one another, against
the spring bias thereof, as shown in FIG. 2A, and then allowed to
close toward one another, according to the spring bias thereof, as
shown in FIG. 2B. Plug portion 70 is shown including an optional
ledge 721 that extends around inner perimeter surface 720 of ring
member 710; if included, ledge 721 preferably extends in proximity
to each end 701, 702 of ring member 710, at the opening of slot
713, to support ends 707, 708 of spring member 730. It should be
noted that, if included, ledge 721 may only extend in proximity to
each end 701, 702. According to some embodiments, anchoring
apparatus 700 further includes a retaining member, for example, a
pin-like tool 715, which is shown inserted between arms 731, 732 of
spring member 730 in FIG. 2A, for example, within a base hole 750
of spring member 730, to hold arms 731, 732 of spring member 730
apart, so that an elongate medical device, for example, lead 15,
which is shown extending out from burr hole 11, may be inserted
into the opening of slot 713 and in between opposing engagement
surfaces 735, for example, by moving apparatus 700 per arrow B.
[0023] According to some methods, after lead 15 is implanted
through the body portal/burr hole 11, for example, via the above
described guidance system 100 (FIG. 1A), lead 15 is positioned
between engagement surfaces 735, and then, with reference to the
elevation view of FIG. 2C, an outer perimeter surface of plug
portion 70, which extends below ring 710, and which is defined by
press fit features 78, is press fit within burr hole 11.
Subsequently, retaining member/tool 715 may be removed, per arrow
Y, to allow arms 731, 732 of spring member 730 to move together
according to the spring bias thereof, thereby anchoring lead 15
between engagement surfaces 735, as illustrated in FIG. 2B. Once
anchored, a proximal portion of lead 15 may be received in one of
channels 714, which are formed in ring member 710, and may guide
routing of the proximal end of lead 15 to another site in the body
for connection to a therapy generator. FIGS. 2A-B further
illustrate outer perimeter surface 740 of ring member 710 having
fastening features extending therefrom, wherein the fastening
features include holes 706 through which screws may be inserted for
fastening the press fit anchoring apparatus 700 to the skull
surrounding burr hole 11, for example, prior to removing the
retaining member to anchor lead 15.
[0024] According to some alternate methods, apparatus 700 may be
positioned around a delivery catheter 105, which extends from the
body portal/burr hole 11, after which plug portion 70 may be press
fit within hole 11, and retaining member/tool 715 removed to
temporarily hold catheter 105 in place while a device, such as lead
15, is delivered therethrough for implant. Then, once lead 15 is
implanted, catheter 105 is withdrawn, over lead 15, out from hole
11, and from between arms 731, 732, to allow engagement surfaces
735 to move together, according to the spring bias of arms 731,
732, and, thereby anchor lead 15.
[0025] A distance between arms 731, 732 in a spring biased closed
position, without lead 15 or any retaining member positioned
therebetween, is preferably less than a diameter of lead 15, for
example, a distance of approximately 0.040 inch when the lead
diameter is approximately 0.055 inch; this interference condition
combined with the material properties of spring member 730 defines
a holding force. Spring member 730 may be integrally formed with
ring member 210, for example, by injection molding, from a
biocompatible polymer material, such as polyurethane,
polycarbonate, polysulfone, polyether ether ketone (PEEK), or
nylon. Alternately, spring member 730 is formed as a separate part,
wherein end 734 is subsequently attached to ring member 710 along
inner perimeter surface 720, as shown. According to an exemplary
embodiment, spring member 730 is formed from a relatively high
durometer polyurethane, and ring member 710 from a relatively low
durometer polyurethane, and then member 730 and ring 710 are
ultrasonically welded, or solvent bonded together. According to
some alternate embodiments, spring member 730 may be formed by
overmolding a metal core, for example, a stainless steel alloy or
nitinol torsional spring, with a biocompatible polymer such as
polyurethane.
[0026] FIG. 2D is a perspective view of an anchoring apparatus 300,
modified from that shown in FIGS. 2A-B, according to some
embodiments. FIG. 2D illustrates apparatus 300 including a central,
or plug portion 30 and a ring member 310, which extends around a
perimeter of plug portion 30; like apparatus 700, apparatus 300 has
slot 713 extending from an opening thereof, formed through ring
member 310, and into plug portion 30. FIG. 2D further illustrates
plug portion 30 including spring biased opposing engagement
surfaces 735 that form opposing sides of slot 713, wherein opposing
sides of slot 713 are defined by opposing arms 331, 332 of a spring
member 330 of plug portion 30. Spring member 330 is similar to
spring member 730 of apparatus 700 in that spring member 330
includes a pair of opposing arms 331, 332, wherein each arm 331,
332 extends between a fixed end 334 of spring member 330, which is
coupled to ring member 310, and a corresponding moveable end 307,
308; but plug portion 30 of apparatus 300 further includes an
elastomer material 33, for example, a medical grade silicone
rubber, that extends between each arm 331, 332 and an inner
perimeter surface 320 of ring member 310, on either side of slot
713, and is compressed when arms are forced apart, for example, by
the above-described retaining member. The inclusion of elastomer
material 33 enhances the spring bias provided by arms 331, 332 to
opposing engagement surfaces 735, and may further enhance sealing
of burr hole, when apparatus 700 is press fit therein. Furthermore,
with reference to the elevation view of FIG. 2C, all or a portion
of press fit features 78 may be formed by an extent of elastomer
material 33.
[0027] A distance between arms 331, 332 in a spring biased closed
position, like arms 731, 732 of apparatus 700, is preferably less
than a diameter of the medical device to be anchored between
engagement surfaces 735, for example, a distance of approximately
0.040 inch, when a device diameter is approximately 0.055 inch.
Spring member 330 may be integrally formed with ring member 310,
for example, by injection molding, from a biocompatible polymer
material, such as polyurethane, polycarbonate, polysulfone,
polyether ether ketone (PEEK), or nylon. Alternately, spring member
330 is formed as a separate part, wherein end 334 is subsequently
attached to ring member 310. According to an exemplary embodiment,
spring member 330 is formed from a relatively high durometer
polyurethane, and ring member 310 from a relatively low durometer
polyurethane, and then member 330 and ring 310 are ultrasonically
welded, or solvent bonded together.
[0028] Methods described above for anchoring an elongate medical
device within a body portal, for example, lead 15 in burr hole 11,
are generally applicable to anchoring apparatus 300. But, according
to alternative methods, another type of retaining member may be
employed with apparatus 300. With further reference to FIG. 2D,
each arm 331, 332 of spring member 330 includes an aperture 305 to
mate with a retaining member, for example, a forceps-type tool used
to spread arms 331, 332 apart from one another, while the elongate
medical device and/or catheter is inserted between engagement
surfaces 735. With further reference to FIG. 2D, in conjunction
with FIG. 2E, following routing of the proximal portion of the
anchored implanted device, for example, being guided by receipt
thereof in one of channels 714, a cap 400 is preferably secured in
place over plug portion 30.
[0029] FIG. 2D illustrates ring member 310 protruding from an upper
surface 312 of plug portion 30, and including a mounting groove 302
and opposing edges 301, which are located on either side of the
opening of slot 713, and which overhang moveable ends 307, 308 of
arms 331, 332. With reference to FIG. 2E, edges 301 and mounting
groove 302 provide mating features for cap 400 to cover upper
surface 312 of plug portion 30, when an outer perimeter edge 402 of
cap 400 is contained within an inner perimeter surface 320 of ring
member 310. According to the illustrated embodiment, a first
perimeter tab 41 of cap 400 may be inserted beneath the overhang of
opposing edges 301 of ring member 310, and a second compressible
tab 42 may be compressed, per arrows C, to fit tab 42 within
mounting groove 302 of ring member 310. FIG. 2E illustrates tab 42
being formed by opposing resilient prongs, each of which includes a
protruding feature 422, which is configured to interlock with a
corresponding sidewall 342 of mounting channel 302 of ring member
310, according to some embodiments.
[0030] FIG. 3A is a perspective view (partially transparent) of an
anchoring apparatus 600, FIG. 3B is a top plan view of apparatus
600, and FIG. 3C is a cross-section view through section line A-A
of FIG. 3B, according to some embodiments. FIGS. 3A-C illustrate
apparatus 600 including a plug portion 680 and a ring member 690,
which extends around a perimeter of plug portion 680, wherein plug
portion 680 and ring member 690 are preferably integrally formed,
for example, from molded medical grade silicone rubber. FIGS. 3A-C
further illustrate plug portion 680 including a top section 691, of
which ring member 690 is an outward extension, and a bottom surface
693, wherein a first slot 630 extends, between top section 691 and
bottom surface 693, from a longitudinally extending opening
(spanning a height H of apparatus 600), at an outer perimeter
surface of both plug portion 680 and ring member 690, to a
longitudinally extending end wall 631, within plug portion 680.
Another, second slot 650 is shown communicating with first slot 630
(best seen in cross-section A-A of FIG. 3C), wherein second slot
650 extends from an opening at top section 691 (spanning a width W
of apparatus 600) to a radially extending end wall 651, within plug
portion 680. FIG. 3C further illustrates an optional channel 697
formed in a lower surface 692 of ring member 690 that projects
radially outward from plug 680.
[0031] With further reference to FIG. 3B, a body portal, for
example, burr hole 11 formed in a skull of a patient, is
schematically represented in proximity to anchoring apparatus 600.
FIG. 3B illustrates delivery catheter 105 inserted through hole 11
to guide a lead 15, which is contained therein, to a target region
of the patient's brain. According to the illustrated embodiment,
apparatus 600 may be positioned around catheter 105 and lead 15,
per arrow I, such that catheter 105 (shown with dashed lines in
FIG. 3C) extends in proximity to end wall 631 of first slot 630,
after which, plug portion 680 may be press fit into hole 11. FIG.
3B further illustrates an outer perimeter surface of plug portion
680 being defined by press fit features 608, which facilitate
insertion into hole 11 and subsequent stability of plug 680 within
hole 11. Following the press fit of plug 680, a distal end of lead
15 may be passed through catheter 105 and implanted in the target
region of the brain, and then catheter 105 withdrawn out from hole
11 and apparatus 600, and over lead 15, to leave a segment of the
implanted lead 15 captured within slot 630. A more proximal portion
of lead 15, which extends outside apparatus 600, may anchor lead
within apparatus 600 according to the bold dashed line of FIG. 3A.
With reference to FIG. 3A, in conjunction with FIGS. 3B-C, the
segment of lead 15 that extends alongside inner end wall 631 of
first slot 630 is designated as a first segment S-1; a more
proximal segment of lead 15, adjacent to first segment S-1, is
designated as a second segment S-2, and is shown extending
alongside adjacent inner end wall 651 of second slot 650; and a
more proximal segment, adjacent to second segment S-2, is
designated as a third segment S-3, and is shown extending around
plug 680 in proximity to lower surface 692 of ring member 690, for
example, being routed along the aforementioned optional channel
697. Thus, lead 15 is anchored with apparatus 600, after inserting
first segment S-1 of lead 15 into first slot 630, by bending second
segment S-2 into second slot 650, and then wrapping third segment
S-3 around plug 680, adjacent to, and beneath the radial projection
of ring member 690.
[0032] FIG. 3D is a perspective view of an anchoring apparatus
600-V, which is similar to apparatus 600, described above. FIG. 3D
illustrates apparatus 600-V including a plug portion 680-V and a
ring member 690-V, which are preferably integrally formed, for
example, from a molded medical grade silicone rubber, and wherein
ring member 690-V is an outward extension of a top section 691-V of
plug portion 680-V. Apparatus 600-V, like apparatus 600, has first
slot 630 extending from an opening, at the outer perimeter surfaces
of ring member 690-V and plug portion 680-V, to longitudinally
extending end wall 630 within ring member 690-V and plug portion
680-V, as best seen in the bottom plan view of FIG. 3E; wherein
first slot 630 communicates with a second slot 650-V, which extends
from an opening at top section 691-V to a radially extending end
wall 651-V within plug portion 680-V. Apparatus 600-V differs from
apparatus 600 in that opposing sides 65 of second slot 650-V open
out from one another, for example, to enclose an angle .theta.
(FIG. 3E), which is between approximately ten degrees and
approximately ninety degrees.
[0033] With further reference to FIG. 3D, it may be appreciated
that lead 15 may be anchored in apparatus 600-V, via segments S-1,
S-2 and S-3 thereof, in a similar manner to that described for
apparatus 600, but that outward opening sides 65 of second slot
650-V help to reduce a profile of apparatus 600-V and lead 15,
anchored therein, in the area where lead 15 exits apparatus 600-V,
which area is designated with reference letter E. FIG. 3D
illustrates apparatus 600-V including press fit features 608 formed
along the outer perimeter surface of plug portion 680-V, similar to
plug portion 680, and apparatus 600-V further including fastening
features in the form of reinforced holes 606 that are formed
through ring member 690-V. According to the illustrated embodiment,
holes 606 are configured to receive screws for fastening anchoring
apparatus 600-V to the skull surrounding burr hole 11, after plug
portion 680-V of apparatus 600-V has been press fit within burr
hole 11. Such holes 606 may also be included in apparatus 600 of
FIGS. 3A-C, according to some embodiments.
[0034] FIGS. 4A-C are perspective views of an anchoring assembly
800, according to yet further embodiments, wherein embodiments of
opposing engagement surfaces are formed in an aperture 813 of a
plate member 810. FIGS. 4A-B illustrate assembly 800 including a
pair of relatively thin plate members 870, 810 positioned adjacent
one another so that a second side 878 of first plate member 870
faces a first side 816 of second plate member 810. Plate members
870, 810 may be formed from titanium or a stainless steel alloy. A
nominal thickness of each plate member 870, 810 may be
approximately 1 mm, and the extent of each plate member 870, 810
is, preferably, slightly curved, according to some embodiments, for
example, to conform to a contour of a skull when secured thereto,
as will be described in greater detail below.
[0035] FIGS. 4A-B further illustrate an inner perimeter edge 872 of
first plate member 870 defining an opening that extends
therethrough, from a first side 876 to second side 878, and
securing/fastening features 808 of first plate member 870 located
in proximity to an outer perimeter edge 874 thereof. Each securing
feature 808 is shown including a hole through which a screw/bone
fastener may be inserted to secure first plate member 870 over a
body portal; and each securing feature 808 is shown projecting from
second side 878 of plate member 870 by a distance d. According to
the illustrated embodiment, a nominal thickness t of second plate
member 810 is less than or approximately equal to distance d so
that, when first plate member 870 is secured to a surface
surrounding the body portal, for example, burr hole 11, second
plate member 810 may fit within the "standoff" between first plate
member 870 and the surface.
[0036] FIGS. 4A-B further illustrate second plate member 810
including an anchoring aperture 813 that is formed therethrough,
from first side 816 to a second side 818 thereof, wherein aperture
813 has opposing engagement surfaces 81 spring biased toward one
another to give aperture 813 a relaxed diameter that is less than
an outer diameter of a device to be anchored therein, for example,
lead 15 (FIG. 4C). Engagement surfaces 81, may be force to expand
from the relaxed diameter, for passage of the device therethrough,
for example, via insertion of a delivery catheter through aperture
813, wherein the delivery catheter has a lumen to receive passage
of the device therethrough. Once the catheter is removed from
around the device, engagement surfaces 81 move back toward one
another, according to the spring bias, to anchor the device in
aperture 813. According to FIGS. 4A-B, aperture 813 is integrally
formed in plate member 810 as a dimple spring clip, but, according
to an alternate embodiment shown in FIG. 4C, opposing engagement
surfaces of anchoring aperture 813 are formed by an elastomer
insert 850, for example, a silicone grommet.
[0037] With further reference to FIGS. 4A-B, second plate member
810 has a shape, defined by an outer perimeter edge 814 thereof,
which, in addition to the aforementioned thickness of second plate
member 810, allows second plate member 810 to be captured between
secured first plate member 870 and the body portal, such that
anchoring aperture 813 is located within a boundary of the opening
defined by inner perimeter edge 872, while each securing feature
806 of second plate member 810 is located outside a boundary
defined by outer perimeter edge 873 of first plate member 870.
Furthermore, the aforementioned standoff provided by the projection
of securing features 808 of first plate member 870 allows the
captured second plate member 810 to be moved, for example,
according to any of the bold arrows shown in FIG. 4A, to reposition
anchoring aperture 813 over the body portal and within the boundary
defined by inner perimeter edge 871, prior to securing second plate
member 810, for example, via screws inserted through holes/securing
features 806, to the surface surrounding body portal.
[0038] FIG. 5 is a flow chart outlining some methods of the present
invention, for example, that employ any of the above-described
embodiments of anchoring apparatus and assemblies. According to
some methods, an elongate medical device, for example, the above
described lead 15, may be inserted between opposing engagement
surfaces of an anchoring apparatus, per step 510, after the device
has been positioned at a target location in a body, via passage
through a body portal, if the anchoring apparatus includes
engagement surfaces formed by opposing sides of a slot, like those
embodiments described above in conjunction with FIGS. 2A-3E.
Following step 510, per path A, the anchoring apparatus is fixed to
the body, for example the skull surrounding cranial burr hole 11,
per step 515, and then a retaining member, which has held the
opposing engagement surfaces apart from one another, against a
spring bias thereof, is removed from between the engagement
surfaces of the apparatus, per step 530, so that the spring bias
moves the engagement surfaces toward one another and into contact
with the inserted device. The retaining member may be a separate
tool, which extends between the engagement surfaces alongside the
inserted device, for example, tool 715 of FIG. 2A, or a delivery
catheter within which the device is received for positioning at the
target location, for example, catheter 105 of FIG. 3B. According to
some alternate methods, the anchoring apparatus is fixed to the
body, per step 515, and then, following path B, the device is
positioned between the opposing engagement surfaces thereof, which
are held apart by the retaining member, per step 510. The
embodiments according to FIGS. 4A-C, which include an anchoring
aperture, are suited for the alternate path B, wherein first plate
member 870 is secured to the body to capture second plate member
810 over the body portal, after which a delivery catheter, as the
retaining member, is inserted through anchoring aperture 813 of
second plate member 810, so that the device may be positioned
between the engagement surfaces of anchoring aperture 813 via
passage through the inserted catheter. It should be noted that a
position of the captured second plate member 810 over the body
portal may be adjusted during the insertion of the catheter and the
passage of the device through the catheter, before securing second
plate member 810 to the body and moving on to step 530. It should
also be noted that slotted embodiments of FIGS. 2A-3E may be
employed per path B as well. With further reference to FIG. 5, in
step 550, the anchoring of device is completed, for example, by
routing a proximal segment of the device into a channel, or another
slot, of the anchoring apparatus. In some cases, following routing,
a cap is secured over the anchoring apparatus.
[0039] In the foregoing detailed description, the invention has
been described with reference to specific embodiments and methods.
However, it may be appreciated that various modifications and
changes can be made without departing from the scope of the
invention as set forth in the appended claims.
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